Clinical trial Recruiting at 2 sites Interventional Ages 14 and up Women only

Improving mental health care for pregnant women with mood and anxiety disorders

Official title: Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics

Run by Kenyatta National Hospital · NCT06456307 · Data updated 2026-11-12

This study is testing a new way to help pregnant women in Kenya who have mood and anxiety disorders by providing better screening and treatment through their regular health care visits.

More Depression, Anxiety trials

Quick facts

Study typeInterventional
Ages14 Years and up
SexWomen only
Enrollment2970 (estimated)
SponsorKenyatta National Hospital
Government
Locations2 sites (Nairobi and 1 other locations)
StatusRecruiting
StartedFebruary 17, 2025
Main results expectedMarch 2028
Study endsMarch 2028
Registry record updatedDecember 10, 2025
Trial IDNCT06456307 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are pregnant women who are at least 28 weeks gestation, attending antenatal care, and screening positive for PMAD symptoms.

Probably not a fit

Patients who are less than 28 weeks gestation or those at high risk of self-harm may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates a stepped-care intervention aimed at screening and treating perinatal mood and anxiety disorders (PMAD) among women attending maternal and child health clinics in Kenya. The intervention includes systematic screening for PMAD symptoms, the use of Problem Management Plus (PM+), and telepsychiatry services to enhance access to mental health care. By integrating mental health services into routine antenatal and postnatal care, the study seeks to improve detection and treatment rates of PMAD, which currently remain low due to inadequate provider training and resources. The trial will assess both clinical outcomes and the implementation of these integrated services in a resource-limited setting.

Why it matters

Potential benefit: If successful, this intervention could significantly improve mental health outcomes for pregnant women experiencing mood and anxiety disorders.

How similar studies have gone: Other studies have shown success in integrating mental health services into perinatal care, but this specific approach in Kenya is novel and untested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Pregnant and ≥28 weeks gestation
* Attending ANC care at the facility
* ≥14 years old
* Screen positive for PMAD symptoms (PHQ-2≥3 and/or GAD-2≥3)
* Willing to return to the MCH and PMTCT clinic for study visits

Exclusion Criteria:

* Less than 28 weeks gestation
* Any woman at high risk of self-harm based on a study self-harm assessment protocol,
* Has cognitive impairments or psychotic symptoms

Where it's running

  • Kenyatta National Hospital
    Nairobi, Kenya
    Recruiting
  • HomaBay, Siaya and Kisumu
    Western Kenya, Kenya
    Recruiting

Study contacts

  • Principal investigator: John Kinuthia, MBChB, MMed, MPH — Kenyatta National Hospital
  • Study coordinator: Nancy Ngumbau, MBChB, MPH
  • Email: nancym390@gmail.com
  • Phone: +254713917226

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.